510(k) Report

FDA product code · Neurology

Device, Nerve Conduction Velocity Measurement

JXEClass II21 CFR 882.1550510(k) required27 decisions since 19761 recall

27 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 427 days (half between 427 and 427). 1 recall names this code; it is not Class I. The most-cited predicate is K013459, named by 3 later devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, neurology panel

Twenty years of JXE at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · JXE

1in 2025

2008: 12019: 12025: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXE

Too few JXE 510(k)s in any year since 2007 to give a median.

Recalls per year · JXE

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JXE

1in 2025

2007: 22008: 12009: 32011: 52012: 62013: 52014: 62015: 42016: 52017: 122018: 82019: 12024: 12025: 1
2007high 12 (2017) · low 0 (2010)2025

MAUDE reports naming product code JXE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20081—01
20090—03
20100—00
20110—05
20120—16
20130—05
20140—06
20150—04
20160—05
20170—012
20180—08
20191—01
20200—00
20210—00
20220—00
20230—00
20240—01
20251—01
20260—0—
FIG. 1 — JXE by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in JXE? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report